Cleared Traditional

TOSHIBA 1.5T EXTRA LARGE KNEE COIL

K103185 · Quality Electrodynamics · Radiology
Feb 2011
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K103185 is an FDA 510(k) clearance for the TOSHIBA 1.5T EXTRA LARGE KNEE COIL, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Quality Electrodynamics (Mayfield Village, US). The FDA issued a Cleared decision on February 25, 2011, 120 days after receiving the submission on October 28, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K103185 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2010
Decision Date February 25, 2011
Days to Decision 120 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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